NCT02881294

Brief Summary

The purpose of the study is to investigate the effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

1.1 years

First QC Date

August 18, 2016

Last Update Submit

September 21, 2017

Conditions

Cognitive Disorders

Outcome Measures

Primary Outcomes (2)

  • Area under concentration (AUC)

    96 hours

  • Maximum observed concentration (Cmax)

    Day 1

Study Arms (3)

Food Effect

ACTIVE COMPARATOR

SUVN-G3031 tablets single dose

Drug: SUVN-G3031

Gender Effect

ACTIVE COMPARATOR

SUVN-G3031 tablets single dose

Drug: SUVN-G3031

Age Effect

ACTIVE COMPARATOR

SUVN-G3031 tablets single dose

Drug: SUVN-G3031

Interventions

SUVN-G3031DRUG
Age EffectFood EffectGender Effect

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female aged 18 to 45 years with a BMI between 18 and 30 kg/m2, (inclusive) for food and gender effect
  • Healthy male aged 60 to 70 years with a BMI between 18 and 32 kg/m2, (inclusive) for age effect

You may not qualify if:

  • History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the study drug.
  • Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody
  • History of any important clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quintiles

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

samelisant

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 26, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

US(1)